Our Services in MD industry - Clariscience

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Medical devices

Regulatory Affairs

Technical documentation Gap Analysis

Classification of medical devices and IVDs

Preparation of the technical documentation

Labelling compliance analysis

Risk analysis activities

Supporting PMS activities

Biological Evaluation Plan e Report

Clinical evaluations (MD), PMCF and SSCP

Assistance for the import of for Medical Devices and IVDs

Support for access to non-EU markets

Medical Device and IVD advertising authorisation

Assistance in interacting with the Notified Body

Person Responsible for Regulatory Compliance

Eudamed and Italian Databases Registration

Regulatory Due Diligence

Performance evaluations (IVD)

Usability assessments

Regulatory helpdesk

Regulatory training

Medical writing and scientific communication

Find out more from our magazine

Regulatory affairs

How to prepare the technical documentation for a medical device

10 October 2023

Sara Simoncioni

The first step in preparing the TD is to create a Technical Documentation template that allows for the inclusion of…

Regulatory affairs

The technical documentation of a Medical Device: Annex II of the MDR

Sara Simoncioni

For all medical devices except custom-made devices, manufacturers are required to draft and maintain up-to-date Technical Documentation in accordance with…